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Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Funding Opportunity Purpose
The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ
SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts. This may include preparation of documents for a Food and Drug Administration (FDA) submission, development of an intellectual property strategy, and/or planning for a clinical trial. Although a significant amount of the work in a CRP award may be subcontracted to other organizations, the SBC is expected to maintain oversight and management of the R and D throughout the award. Clinical trials not accepted under this FOA.
SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Not Allowed
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award.
SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award.
Discovery of Biomarkers and Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
Funding Opportunity Purpose
The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and/or early evaluation of strong candidate biomarkers and biomarker signatures that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Although research supported by this FOA can include animal studies, it must also include preliminary human evaluation using carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.
Molecular Mechanisms of Blood-Brain Barrier Function and Dysfunction in Alzheimer's disease and Alzheimer's related dementias (AD/ADRD) (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The goal of this initiative is to elucidate the mechanistic links between blood brain barrier (BBB) dysfunction, Alzheimers disease (AD) and AD-related dementias (ADRD), and how related comorbidities impact the basic molecular mechanisms of BBB health and function.
BRAIN Initiative: Non-Invasive Neuromodulation - New Tools and Techniques for Spatiotemporal Precision (R01 Clinical Trial Optional)
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) solicits grant applications in two related but distinct areas. The first area is in the development and testing of novel tools and methods of neuromodulation that go beyond the existing forms of neural stimulation. The second distinct area that this FOA seeks to encourage is the optimization of existing stimulation methods.
BRAIN Initiative: Development of Next Generation Human Brain Imaging Tools and Technologies (U01 Clinical Trial not allowed)
Funding Opportunity Purpose
This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, aims to support full development of entirely new or next generation noninvasive human brain imaging tools and methods that will lead to transformative advances in our understanding of the human brain. The FOA seeks innovative applications that are ready for full-scale development of breakthrough technologies with the intention of delivering working tools. This FOA represents the second stage of the tool/technology development effort that started with RFA-MH-14-217 and RFA-MH-15-200
BRAIN Initiative: Proof of Concept Development of Early Stage Next Generation Human Brain Imaging (R01 Clinical Trial Not Allowed)
Funding Opportunity Purpose
This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, aims to support early stage development of entirely new and novel noninvasive human brain imaging technologies and methods that will lead to transformative advances in our understanding of the human brain. The FOA solicits unusually bold and potentially transformative approaches and supports small-scale, proof-of-concept development based on exceptionally innovative, original and/or unconventional concepts.
NINDS Child Neurologist Career Development Program (CNCDP) (K12 Clinical Trial Not Allowed)
Funding Opportunity Purpose
The purpose of the NINDS Child Neurologist Career Development Program (CNCDP) is to facilitate and support the research career development of child neurologists who have made a commitment to independent research careers. The CNCDP is a single national program, implemented by one or more PD/PIs and, if applicable, co- directors (at least one of whom is the PD/PI), together with an advisory committee composed of basic and clinical investigators who have a strong record of funded research and successful training of clinician scientists. The CNCDP will generally provide three consecutive years of support to individuals to provide them with the knowledge, tools and research experience that will enable them to develop a significant research project funded by an individual career development award or research grant. This Funding Opportunity Announcement (FOA) does not allow appointed scholars to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.